|
Device | Tendril MRI Low Voltage Leads |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S043 |
Date Received | 11/23/2018 |
Decision Date | 12/05/2018 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Introduce periodic particulate matter testing and equipment to the Malaysia and Puerto Rico manufacturing facilities. |